This course is intended for individuals who have the responsibility for establishing the integrity of analytical methods for active pharmaceutical ingredients (APIs) or finished pharmaceutical dosage forms. This course will benefit individuals in:

  • QA managers and personnel
  • Quality control scientists
  • Method development scientists
  • Analytical chemists
  • Validation specialists
  • Laboratory managers and supervisors
  • Regulatory affairs professionals
  • Training departments
  • Documentation departments
  • Consultants

Results of analytical methods are used as the basis for important decisions during development and manufacturing of pharmaceutical products. All regulatory agencies expect the pharmaceutical industry to have procedures in place to ensure suitable levels of reliability, accuracy and precision of such methods. The procedures should cover lifecycle phases from design, development, validation to on-going routine use.

Managing analytical methods and procedures according to the lifecycle approach has been recommended in recent FDA guidance documents and stimuli articles published by the USP. For example, the recent FDA guidance “Analytical Procedures and Methods Validation for Drugs and Biologics” contains a section on Lifecycle Management of Analytical Procedures, and ICH has recently published guidelines on product lifecycle management.

This 2-day course will explain the background to the new Analytical Procedure Lifecycle guidelines and give attendees the knowledge needed to implement recommended approaches.


Agenda
DAY 01(10:00 AM - 5:00 PM EDT)
10.00 AM - Session Start

Introductions and Agenda Review Lectures

Lecture 1 - Regulatory background and guidance

  • The importance of analytical procedures
  • ICH Q12
  • Introduction to lifecycle management of analytical methods
  • USP approach for method validation: in-process revisions to Chapters 1200, 1210 and 1225
  • Learnings from the new FDA, WHO and PDA method validation guidelines
  • Linking the procedure lifecycle to the quality system
  • The importance of risk management (ICH Q9)
  • Lessons from recent FDA Warning Letters
  • Recommendations for risk-based implementation

Lecture 2 - The 2015 FDA Method Validation guidance

  • Scope and regulatory status
  • Recommendations for integrated procedure lifecycle
  • Expectations for quality risk assessment, Quality by Design (QbD), Multivariate experiments, system suitability testing, statistics, knowledge management
  • Equipment operational qualification and trend analysis
  • Revalidation vs. ongoing evaluation

Lecture 3 - Preparing your laboratory for compliant validation studies

  • Analytical Instrument qualification
  • 21 CFR Part 11/Annex 11 compliance of computer systems
  • Validation of chromatographic data systems
  • Validation and control of Excel spreadsheets
  • Qualification of reference standards and materials

Lecture 4 - The lifecycle overview on integrated method development, validation, and ongoing performance verification

  • Advantages of the new approach
  • Key steps for design, development, validation and ongoing performance verification
  • Integrated lifecycle and QbD: similarities, differences
  • Regulatory status of the new approach
  • Integrating method transfer and compendial method verification
  • Application of risk management through the life cycle

DAY 02(10:00 AM - 5:00 PM EDT)

Lecture 5 - The analytical target profile

  • Comparison with the scope of current methods
  • Advantages and limitations of the ATP approach
  • Introduction to measurement uncertainty
  • Target measurement uncertainty (TMU)
  • Considerations for establishing an ATP
  • Incorporating current USP, ICH and FDA guidance into the ATP
  • Constructing an ATP for existing methods

Lecture 6 - Procedure design and development

  • Knowledge gathering: what and how
  • Risk management: assessment, evaluation and control
  • Analytical control strategy
  • Typical control examples
  • Illustration of controls using Ishikawa (fishbone) diagrams
  • Knowledge management as an important factor in ensuring the acquiring, analyzing, storing and disseminating information

Lecture 7 - Procedure Performance Qualification (Validation)

  • Developing a validation/qualification plan and SOP
  • ICH Q2 validation and test parameters:
  • Accuracy, precision, intermediate precision, specificity, LOD, LOQ, linearity, range, robustness
  • Examples for design and execution of test experiments
  • Examples of application-specific acceptance criteria
  • Evaluation of test results: using statistical models

Lecture 8 - Ongoing Performance Verification

  • Objective of ongoing performance verification
  • Monitoring method performance: system suitability testing and quality control samples
  • Handling of method changes vs. permitted adjustments
  • Revalidation of analytical methods: when, what to test
  • Handling of out-of-expectation results

Learning Objectives:
  • Learn about the regulatory background and recommendations for managing the lifecycle of analytical methods and procedures
  • Understand current and future industry trends: the concept of lifecycle management of analytical methods, recent USP General Chapter 1210 (Statistical Tools for Procedure Validation), and Quality by Design (QbD) principles for method development and validation
  • Learn how to plan, execute and document design, development and validation of methods developed in-house
  • Understand the principles of lifecycle management for compendial procedures and for managing method transfer
  • Be able to develop a strategy for analytical procedure lifecycle management
  • Understand risk management strategies throughout the procedure lifecycle
  • Understand the concept of measurement uncertainty
  • Be able to justify and document decisions about type and extend of revalidation after method changes
  • Be able to define and demonstrate FDA, EU, USP and ICH compliance to auditors and inspectors
  • Be able to develop inspection-ready documentation during on-going routine operation
  • Understand what questions will be asked during audits and inspections and how to answer them

In Partnership With Compliance Online




Faculty Dr Mark Powell
Director, Mark Powell Scientific Limited

Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as an analytical chemist. Mark was Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016, when his term of office ended. Between 2003 and 2013, he was the Analytical Development Manager, and later Scientific Manager, of a UK-based contract research organization which specialized in early-stage oral drug development. During this time, he was responsible for method validation, verification and transfer activities, as well as the qualification of laboratory instruments and computerized data systems. In 2013, he set up Mark Powell Scientific Limited, which provides training and consultancy services to pharmaceutical companies. Mark has since enjoyed working with companies of all sizes around the world on a variety of training and consultancy assignments, and has recently co-authored a White Paper on Pharmaceutical Data Integrity for the laboratory supply company VWR.